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Many new pharma development projects and lifecycle management opportunities are exploring the integration of medical devices with drug products as the industry seeks more convenient, user-focused drug delivery solutions. These emerging solutions often fall under the designation of ‘combination products’, where regulation, guidelines and applicable standards have evolved rapidly. Such a strong growth in this sector of the pharma industry has raised significant requirements on development, clinical supply, design transfer, risk management and commercial supply. For many pharma companies, the investment, facilities, equipment, process controls and challenges associated with meeting the new corresponding manufacturing requirements are still not fully understood, and can be therefore quite burdensome. Identifying and engaging established, competent and experienced external providers such as a global CDMO is an excellent alternative.
In order to meet its partners’ increasing demands, CordenPharma has consistently invested in expanded capabilities, including most recently, a brand new R&D facility & team to support several Drug Product development projects from early-stage formulation and clinical manufacture supply to late-stage commercial scale-up, with a particular focus on device-combination products.
Moreover, the CordenPharma Injectable site is progressing on its injectable roadmap to the completion of a Large-scale Commercial Aseptic Fill & Finish facility, able to process either Pre-Filled Syringes (PFS), Cartridges or Vials in a new plant now approved by the US FDA & AIFA (EMA).
This Webinar will review the topic of combined drug-device products, provide an update of the regulatory landscape with a particular focus on injectable drugs, and highlight how CDMOs such as CordenPharma are uniquely placed to help pharma Drug Developers, Regulatory, Clinical Supply, R&D and Tech Transfer Managers, External Quality, Business Development or Heads of Procurement & Supply Chain navigate the injectable combination drug product challenges ahead, especially in the “New Normal” COVID-19 era.
As participant, you will gain some key insights into understanding what IS and what IS NOT a combined drug-device product, some technical challenges for injectable Pre-Filled Syringes (PFS) & Autoinjectors, important aspects such as sound injectable drug product strategy to consider before making your CDMO selection, and specific recommendations on finding solutions for injectable combination device-drug product challenges integrated with CordenPharma’s manufacturing capabilities.
REGISTER NOW for this specially-designed webinar given by three key speakers representing the exciting and dynamic combined injectable drug product and delivery device industry from different angles:
Principal Consultant & Company Director
Corvus Device Ltd.
Mark serves as an independent consultant to the Pharma and Medical Device industries via his company Corvus Device Ltd. He has over twenty years of experience in Medical Device, Drug Delivery Device and Combination Products across Technical Development, Operations, Regulatory/Quality Compliance and product maintenance – from a range of roles with GSK, Sanofi-Aventis, Novartis and F. Hoffmann-La Roche.
Through his career to date he has been heavily involved in development of medical devices for combination products in several forms: syringes, pen injectors, auto-injectors, patch injectors, solution/suspension inhalers, multi-dose disposable and reusable dry powder inhalers, convenience kits, dispensers and special purpose applicators.
He has performed numerous due diligence and technical evaluations of novel delivery technologies; developed products through the full design control phases to market; and maintained marketed products. Mark is a veteran of several successful IND/CTA/NDA/BLA/MAA submissions and approvals that have included drug delivery devices. He has experienced many of the challenges associated with delivery device development and device product maintenance within large pharmaceutical companies and implemented Medical Device development guidance, quality systems and business processes.
Qualified with a master’s degree in Engineering Management from Loughborough University and a Bachelor’s Degree in Mechanical Engineering from London South Bank, he has maintained Continuous Professional Development with supplemental and progressive training in areas such as Technical, Manufacturing, Risk Management, Quality & Compliance, Technical Authorship, Project Management and Leadership.
Director, Global Injectables Platform
Fabio Stevanon has 25+ years of experience in the pharmaceutical industry, and is currently the Global Injectable Platform Director at CordenPharma International. He has broad responsibilities to support and develop CordenPharma’s Injectable platform with the best capabilities, technologies and strategy for pharma market-specific needs. Prior to his current role, he held responsibility in Business Development, Supply Chain & Procurement within the Corden Pharma SpA Injectable facility at Caponago, IT, close to Milano. Before 2009, when the facility was still part of AstraZeneca, he worked as Supply Chain Director in a global project leader role on specific business areas related to lean activities & Business Process Reengineering. Fabio graduated with a degree in Engineering from Politecnico Milano in Italy.
CordenPharma Caponago (IT)
Umberto Romeo has over 10 years of experience in drug product process design, development and manufacturing of chemical & biological compounds throughout all stages of development up to commercialization. He is currently the R&D Manager at CordenPharma Caponago, with main responsibilities for leading injectable drug product formulation, analytical development and industrialization activities. Prior to his current role, he worked as Project & Alliance Manager in Evotec managing complex projects (from Discovery – Phase 3) to successful completion, covering all phases of the project management process (initiation, planning, execution, monitoring & control, and closure), in addition to leading project teams to deliver results within the constraints of schedule.
He also worked at UCB as a Drug Product Process Design & Development Principal Scientist where he was responsible for CMC development activities of Biopharmaceuticals, with a focus on Drug Product Process Design, Development & Technology Transfer to GMP manufacturing sites. In this role, he also established a Drug Product Process Design & Development department leading a team of 6 people, as well as supported the CMC development program of the whole UCB biological pipeline.
Additionally, he worked in Patheon Inc. as a Technology Transfer Project Manager, where he successfully managed the technology transfer of more than 15 drug product manufacturing processes for oral, injectable lyophilized and liquid drug products for European, US, Japanese and ROW markets at Phase 3 /commercial-scale.
Umberto graduated with a degree in Pharmaceutical Biotechnologies from Milano State University (IT).